FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
63187-695
11-digit product format
631870695
Labeler code
63187
Product ID
63187-695_04942785-402c-49ca-a03d-6b69609673a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-695-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65
63187-695-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET105
63187-695-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET145
63187-695-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET205
63187-695-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET285
63187-695-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-695-06EA - Each63187-695aa315806-ef58-4a55-86c3-316a0ceec6e812018-02-20
63187-695-10EA - Each63187-695199b0fd9-ad03-4537-a6de-f65a3356700112017-03-06
63187-695-14EA - Each63187-6953b4762a6-519d-4c02-a10e-db684133e30212017-03-06
63187-695-20EA - Each63187-69530e4de50-f3e5-4487-b3d2-27b05f91cc6612017-03-06
63187-695-28EA - Each63187-695db804c00-663a-4906-996a-0bcd1b49da9b12017-04-05
63187-695-40EA - Each63187-6953f8340f7-b362-4fa7-997b-562970c30d1112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-695SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 6 package rows20220513_29e83667-8d4a-49b7-9182-653cbfb2dee7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN29e83667-8d4a-49b7-9182-653cbfb2dee75
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD29e83667-8d4a-49b7-9182-653cbfb2dee75
198335SMX 800 MG / TMP 160 MG Oral TabletSY29e83667-8d4a-49b7-9182-653cbfb2dee75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-695-06631870695066 TABLET in 1 BOTTLE (63187-695-06) 6 tablet2016-12-010000-00-00NoNoCurrent
63187-695-106318706951010 TABLET in 1 BOTTLE (63187-695-10) 10 tablet2016-12-010000-00-00NoNoCurrent
63187-695-146318706951414 TABLET in 1 BOTTLE (63187-695-14) 14 tablet2016-12-010000-00-00NoNoCurrent
63187-695-206318706952020 TABLET in 1 BOTTLE (63187-695-20) 20 tablet2016-12-010000-00-00NoNoCurrent
63187-695-286318706952828 TABLET in 1 BOTTLE (63187-695-28) 28 tablet2016-12-010000-00-00NoNoCurrent
63187-695-406318706954040 TABLET in 1 BOTTLE (63187-695-40) 40 tablet2016-12-010000-00-00NoNoCurrent